Associate Director, Regulatory Affairs Europe

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. We have a new, exciting opportunity for an Associate Director Regulatory Affairs Europe role to be based in London (UK), Brussels (Belgium) or Oss (The Netherlands).

In this role you will coordinate regulatory activities in the EU, UK, Switzerland and ex-EU Central Europe South countries, with mínimal guidance of the Executive Director. We operate a hybrid working model.

Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety. We are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Our current portfolio in Vaccines, Infectious diseases and General Medicine is creating countless opportunities and challenges for the team. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day

**Responsibilities**:

- Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions in the EU, UK, Switzerland and non-EU countries.
- For assigned development of marketed products and lead cross-functional teams.
- Work with project teams to develop and implement regulatory strategies, identify regulatory risks and enable earliest possible approval. Ensure regulatory strategies are aligned with project teams, business objectives and deliverables.
- Accountable for Agency interactions to ensure a seamless submission, assessment and quick approval of clinical trial operations under the new EU Clinical Trial Regulation, in liaison with the regulatory affairs teams in the region and other internal stakeholders.
- Serve as a principal regulatory contact with regulatory agencies and Country Regulatory Affairs teams.
- Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams. Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements
**Your profile**:

- M.D., Ph.D. or Master degree with at between 3-4 years of experience in clinical research or regulatory affairs is required. Individuals who have demonstrated competence in biomedical research gained through appropriate experience of 1-2 years and who possess an excellent working knowledge of Regulatory Affairs or Clinical Research gained within industry or regulatory authorities would be considered.
- Advanced, interpersonal written and oral communication skills; advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment.
- Able to manage complex projects by exercising independent decision making and analytical thinking skills.
- Knowledge of EU regulations, guidelines, regulatory processes for non-EU countries and product life cycle maintenance.
- Ability to work in cross-functional and international environment.
- Detail and goal-oriented, quality conscientious, and customer-focused.
- Ability to adhere to strict project timelines; strong team player; good judgment and problem-solving skills, with ability to identify, analyze and resolve problems in a timely manner.
- Fluent written and spoken English is required.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace

**Who we are **

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative healt